Sat.Feb 04, 2023 - Fri.Feb 10, 2023

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Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics

Fierce Pharma

Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics fkansteiner Tue, 02/07/2023 - 10:08

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The Preprint Citation Index: linking preprints to the trusted Web of Science ecosystem

Clarivate

After many months of planning, we are launching the Preprint Citation Index , a multidisciplinary collection of preprints from leading repositories that helps researchers stay current with the newest research while maintaining confidence in the resources they rely on. With the launch of the Preprint Citation Index , we are making it even easier for researchers to include preprints in their existing research workflows.

Leads 145
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Blue Shield of California Adds Virta Health to Network for Diabetes Care

MedCity News

Virta is available this month to all Blue Shield of California members enrolled in preferred provider organization plans for individual and family, fully insured, self funded and Medicare Advantage. The payer has been working with Virta since 2019 when the digital health company joined Blue Shield of California’s Wellvolution, a platform of digital lifestyle apps.

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Tiny Patch for Cardiac Ultrasound Imaging

Medgadget

Engineers at the University of California San Diego have developed a wearable ultrasound system for cardiac imaging. The postage stamp-sized patch can be worn on the skin of the chest and uses AI and ultrasound waves to perform advanced imaging of the heart. The technology can even be worn to perform cardiac ultrasound imaging during exercise. Each patch can be worn for up to 24 hours, and provides information on how much blood the heart is pumping, a key metric in detecting and appraising a var

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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BREAKING: Bayer taps Roche vet Anderson as its next CEO, pushing out Baumann

Fierce Pharma

BREAKING: Bayer taps Roche vet Anderson as its next CEO, pushing out Baumann esagonowsky Wed, 02/08/2023 - 11:28

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

A wave of important legislative changes is anticipated in the EU in 2023 making this year one of the biggest for the EU regulatory landscape governing the life sciences industry in recent times. Changes have been spurred by the COVID-19 pandemic, which emphasised the need to urgently modernise outdated EU pharmaceutical law and revise regulatory ambitions in the MedTech sector.

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Alvotech proposed biosimilar to Stelara accepted by EMA

PharmaTimes

The companies anticipate that the EMA could also recommend marketing authorisation for AVT04

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AstraZeneca's Forxiga nabs expanded heart failure approval in Europe

Fierce Pharma

AstraZeneca's Forxiga nabs expanded heart failure approval in Europe zbecker Tue, 02/07/2023 - 14:24

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Astellas and Bayer announce management changes

European Pharmaceutical Review

Changes to management for Big Pharma companies Astellas and Bayer AG have been announced for 2023. Astellas Astellas Pharma Inc. has approved changes of its Representative Director, President and CEO and its management structure. Effective April 1, 2023, Naoki Okamura and Kenji Yasukawa will hold the following positions: Naoki Okamura is currently Representative Director, Executive Vice President of Astellas.

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Report: 88% Of Employers Are Planning Changes to Health Vendor Partnerships

MedCity News

Employers are most interested in switching up their vendor partners for wellbeing programs, the Willis Towers Watson survey found. About 55% of respondents said they will make changes to their wellbeing vendor partners in 2023 or 2024, while 12% already did in 2022.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Vygon and University hospital of Wales in heart patient partnership

PharmaTimes

Collaboration has created method for heart failure patients to receive at-home treatment

Patients 107
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Novartis, Bayer marshal relief for Turkey and Syria following devastating earthquake

Fierce Pharma

Novartis, Bayer marshal relief for Turkey and Syria following devastating earthquake fkansteiner Wed, 02/08/2023 - 09:56

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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

FDA 105
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Specialty Pharmacy Needs a Shake Up to Help the Chronically Ill

MedCity News

For anyone suffering from a debilitating or life-threatening disease, the experience of procuring specialty medications […]

Medical 118
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Positive data from LEO Pharma’s delgocitinib cream trial

PharmaTimes

Study involves the treatment of adults with moderate-to-severe chronic hand eczema

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ICER chief's agenda: Gene therapy differentiation, post-IRA model updates and more

Fierce Pharma

ICER chief's agenda: Gene therapy differentiation, post-IRA model updates and more aliu Tue, 02/07/2023 - 10:30

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Pharma Governance and the Quest for Gender Equity

PharmExec

Examining efforts to boost women representation on company boards.

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Evernorth: Suicide-related Behavior Is on the Rise for American Youth

MedCity News

Suicide-related diagnoses in children and adolescents increased 14% since before the pandemic, a new Evernorth analysis shows. Female and Asian/Pacific Islander youth are especially struggling.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.

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Despite high-profile media coverage, FDA balks at GSK's 'unprecedented' Jemperli proposal in rectal cancer

Fierce Pharma

Despite high-profile media coverage, FDA balks at GSK's 'unprecedented' Jemperli proposal in rectal cancer aliu Tue, 02/07/2023 - 17:07

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Novel two-chamber setup could predict HPAPI dustiness

European Pharmaceutical Review

Researchers have shown that a newly developed two-chamber setup (TCS) for containment investigations consisting of an emission and a detection chamber may predict highly potent active pharmaceutical ingredient (HPAPI) dustiness in a sealed system at different flow conditions. These different flow conditions include the plain diffusive transport and the diffusive transport with the oppositely directed convective flow of airborne particles of the safe surrogate substance acetaminophen (ACAM).

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HLTH Foundation’s Achievements and Ambitions for Health Equity [Sponsored]

MedCity News

HLTH Foundation Executive Director Janna Guinen described its focus on promoting equity, inclusion and opportunity in healthcare on behalf of patients, healthcare professionals and health tech entrepreneurs.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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FDA grants approval to Gilead Sciences’ breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients. Trodelvy has been approved for HR+/HER2- breast cancer adult patients who have previously received endocrine-based therapy and a minimum of two additional systemic therapies

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AstraZeneca met CEO Pascal Soriot's $40B revenue goal early. Now, it plans 15 drug launches by 2030

Fierce Pharma

AstraZeneca met CEO Pascal Soriot's $40B revenue goal early.

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FDA gives first RMAT designation to a cardiac gene therapy

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 is the first cardiac gene therapy to receive RMAT designation from the FDA,” commented Dr Gaurav Shah, Chief Executive Officer at Rocket Pharmaceuticals.

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Pharma Returns Slump as Post-Pandemic Realities Set In, Deloitte Report Says

MedCity News

R&D spending rose in response to Covid-19, bringing with it higher expectations for returns on all biopharma investments. The once sky-high projections are coming down to Earth, with returns now in line with pre-pandemic levels, according to a new Deloitte report.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases.

FDA 105
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Regeneron wins another FDA nod for powerhouse Eylea despite trial flops

Fierce Pharma

Regeneron wins another FDA nod for powerhouse Eylea despite trial flops kdunleavy Thu, 02/09/2023 - 10:30

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Pharmacists to receive further mental health training

PharmaTimes

The pathway is a programme designed to develop pharmacists’ knowledge of mental health among patients

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California lawsuit targets insulin costs as Biden also takes aim in SOTU

MedCity News

High prices have drawn other critics, as well, including President Joe Biden. He renewed his call for a broad price cap during his annual State of the Union address. Pharma companies insist they have been part of the solution.

Pharma 111
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time